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Issues in Risk Assessment (1993)
Commission on Life Sciences (CLS)

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. "5 Conclusions ." Issues in Risk Assessment. Washington, DC: The National Academies Press, 1993.

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Issues in Risk Assessment

5
Conclusions

  • Risk assessment is defined as a general process for linking science to decision-making. Definitions and concepts for ecological risk assessment can be defined analogously with those provided for human health risk assessment in the NRC's 1983 report, Risk Assessment in the Federal Government: Managing the Process. The scope of ecological risk assessment, defined in this way, is not limited to technical analyses supporting day-to-day regulatory decisions. Ecological risk assessment can also contribute to strategic planning within and between federal agencies and to clarifying the ongoing public debate concerning national and international environmental priorities.

  • The four-part framework for health risk assessment (hazard identification, dose-response assessment, exposure assessment, risk characterization) described in the 1983 report insufficiently characterizes the interaction between science and management in risk assessment. Management considerations (e.g., regulatory constraints on the scope or time available for an assessment for legally prescribed definitions of acceptable or unacceptable risks) shape the hazard identification step. Communication of risks in terms relevant to decision-making is a critical aspect of risk characterization that was largely unexplored in the 1983 report. (This topic was explored in a subsequent NRC report, Improving Risk Communication (NRC, 1989)). Although the deficiencies were initially identified by the committee with respect to ecological risk assessment, the committee believes they are relevant to human health risk assessment as well.

Page
265
Front Matter (R1-R18)
Executive Summary (1-2)
USE OF THE MAXIMUM TOLERATED DOSE IN ANIMAL BIOASSAYS FOR CARCINOGENICITY (3-8)
THE TWO-STAGE MODEL OF CARCINOGENESIS (9-9)
A PARADIGM FOR ECOLOGIC RISK ASSESSMENT (10-12)
Issues In Risk Assessment Use Of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity (13-14)
BACKGROUND (15-17)
SCOPE OF REPORT (18-20)
DEFINITIONS AND BACKGROUND (21-23)
CORRELATIONS (24-32)
RELATIONSHIP BETWEEN TOXICITY AND CARCINOGENICITY OBSERVED AT MTD (33-42)
QUALITATIVE INFORMATION (43-48)
QUANTITATIVE INFORMATION (49-52)
OPTION 1 (53-53)
OPTION 2 (54-54)
OPTION 3 (55-56)
Option 4A (57-58)
Option 4B (59-60)
5 Conclusions and Recommendations (61-66)
REFERENCES (67-78)
BACKGROUND (79-79)
DEFINING AND DETERMINING THE MTD (80-90)
Appendix B Organizing Subcommittee (91-92)
Appendix C Federal Liaison Group (93-94)
Appendix D Workshop Program (95-96)
Appendix E Workshop Attendees (97-110)
1. INTRODUCTION (111-112)
2.1 Measures of Carcinogenic Potency (113-115)
2.2 Carcinogenic Potency Database (CPDB) (116-116)
2.3 Variation in Carcinogen Potency (117-118)
2.4 Classification of Carcinogens (119-120)
3.1 Empirical Correlations (121-124)
3.2 Range of Possible TD50 Values (125-125)
3.3 Analytical Correlations (126-127)
3.4 Model Dependency (128-129)
3.5 Genotoxic vs. Nongenotoxic Carcinogens (130-130)
4.1 Predictions Based on the MDT (131-131)
4.2 Predictions Based on Mutagenicity and Acute Toxicity (132-134)
5.1 Correlation Between Upper Bounds On the Low Dose Slope and MTD (135-135)
5.2 Correlation Between q1* and the TD50 (136-138)
5.3. Preliminary Estimate of Risk (139-139)
6. INTERSPECIES EXTRAPOLATION (140-140)
6.1 Extrapolation from Rats to Mice (141-143)
6.2 Extrapolation from Rodents to Humans (144-145)
7. CONCLUSIONS (146-148)
8. ACKNOWLEDGEMENTS (149-149)
9. REFERENCES (150-159)
ANNEX A: MAXIMUM LIKELIHOOD METHODS FOR FITTING THE WEIBULL MODEL (160-161)
ANNEX B. SHRINKAGE ESTIMATORS OF THE DISTRIBUTION OF CARCINOGENIC POTENCY (162-163)
ANNEX C: ADJUSTMENT OF POTENCY VALUES FOR LESS THAN LIFETIME EXPOSURE (164-165)
ANNEX D: CORRELATION BETWEEN TD50 AND MTD (166-168)
ANNEX E: CORRELATION BETWEEN TD50S FOR RATS AND MICE (169-172)
Appendix G Informal Search for ''Supercarcinogens" (173-174)
CRITERIA AND CANDIDATE CHEMICALS (175-176)
DATA (177-180)
RESULTS (181-181)
DISCUSSION (182-184)
Issues in Risk Assessment The Two-Stage Model Of Carcinogenesis (185-186)
INTRODUCTION (187-187)
BIOLOGIC CONSIDERATIONS (188-189)
THE TWO-STAGE MODEL (190-195)
APPLICATIONS OF THE TWO-STAGE MODEL TO ANIMAL DATA (196-211)
Data Needs (212-212)
Criteria for Adoption (213-213)
Prospects (214-214)
CONCLUSIONS AND RECOMMENDATIONS (215-216)
REFERENCES (217-222)
BIOLOGICAL FACTORS IN TWO-STAGE MODELS (223-225)
TWO-STAGE MODEL OF CLONAL EXPANSION (226-227)
APPLICATION OF THE TWO-STAGE MODEL TO ANIMAL DATA (228-232)
Appendix B Workshop Program (233-234)
Appendix C Workshop Federal Liaison Group (235-236)
TOPIC GROUP MEMBERS (237-238)
Appendix E Workshop Organizing Task Group (239-240)
Isuees In Risk Assessment A Paradigm for Ecological Risk Assessment (241-242)
1 Introduction (243-246)
2 Scope of Ecological Risk Assessment (247-248)
COMPONENTS OF THE 1983 FRAMEWORK (249-250)
CONSISTENCY OF CASE STUDIES WITH THE 1983 FRAMEWORK (251-253)
INTEGRATION OF ECOLOGICAL RISK INTO THE 1983 FRAMEWORK (254-254)
DEFINITION OF FRAMEWORK COMPONENTS FOR ECOLOGICAL RISK ASSESSMENT (255-258)
EXTRAPOLATION ACROSS SCALES (259-260)
QUANTIFICATION OF UNCERTAINTY (261-261)
VALIDATION OF PREDICTIVE TOOLS (262-262)
VALUATION (263-264)
5 Conclusions (265-266)
6 Recommendations (267-268)
REFERENCES (269-272)
Appendix A Workshop Participants (273-278)
Appendix B Workshop Organizing Subcommittee and Federal Liaison Group (279-280)
Appendix C Workshop Introduction (281-282)
TERRY F. YOSIE BUILDING ECOLOGICAL RISK ASSESSMENT AS A POLICY TOOL (283-285)
D. WARNER NORTH: RELATIONSHIP OF WORKSHOP TO NRC'S 1983 RED BOOK REPORT (286-288)
MICHAEL SLIMAK: U.S. ENVIRONMENTAL PROTECTION AGENCY ACTIVITIES IN ECOLOGICAL RISK ASSESSMENT (289-292)
CASE STUDY 1: TRIBUTYLTIN RISK MANAGEMENT IN THE UNITED STATES (293-293)
Discussion (294-294)
CASE STUDY 2: ECOLOGICAL RISK ASSESSMENT FOR TERRESTRIAL WILDLIFE EXPOSED TO AGRICULTURAL CHEMICALS (295-296)
CASE STUDY 3A: MODELS OF TOXIC CHEMICALS IN THE GREAT LAKES: STRUCTURE, APPLICATIONS, AND UNCERTAINTY ANALYSIS (297-298)
CASE STUDY 3B: ECOLOGICAL RISK ASSESSMENT OF TCDD AND TCDF (299-299)
Discussion (300-300)
CASE STUDY 4: RISK ASSESSMENT METHODS IN ANIMAL POPULATIONS: THE NORTHERN SPOTTED OWL AS AN EXAMPLE (301-301)
Discussion (302-302)
CASE STUDY 5: ECOLOGICAL BENEFITS AND RISKS ASSOCIATED WITH THE INTRODUCTION OF EXOTIC SPECIES FOR BIOLOGICAL CONTROL OF A... (303-303)
Discussion (304-304)
CASE STUDY 1: UNCERTAINTY AND RISK IN AN EXPLOITED ECOSYSTEM: A CASE STUDY OF GEORGES BANK (305-306)
Discussion (307-308)
Generic Issues (309-309)
Analysis of Case Studies (310-310)
DOSE-RESPONSE ASSESSMENT (311-311)
Selection of End Points (312-312)
Consideration of Nonlinearities And Discontinuities (313-313)
Understanding the Stressor (314-314)
Additions to the 1983 Paradigm Needed for Ecological Risk Assessment (315-315)
Modeling Needs for Stress-Response Relationships (316-316)
Methods of Measuring Stressors for Ecological Exposure Assessment (317-317)
Definition of Risk Characterization (318-318)
Components of Risk Characterization (319-319)
Organization and Presentation (320-320)
Differences from and Similarities To the 1983 Report (321-321)
Application to the Case Studies (322-323)
Agricultural Chemicals (324-324)
Northern Spotted Owl (325-325)
General Discussion: Models and Risk Assessment (326-326)
Uncertainties Identified In the Case Studies (327-327)
Implications of Uncertainty for Ecological Risk Assessment (328-328)
VALUATION (329-330)
Risk Assessment Has Many Uses (331-332)
Different Risk Assessment Methods Are Suited to Different Risk Assessment Needs (333-333)
Risk Assessors and Risk Managers Need to Communicate (334-334)
Credibility is Crucial (335-336)
Appendix G Contemplations on Ecological Risk Assessment (337-342)
Appendix H Workshop Summary (343-346)
Appendix I References for Appendixes (347-350)
Appendix J Workshop Program (351-356)

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OCR for page 265
Issues in Risk Assessment 5 Conclusions Risk assessment is defined as a general process for linking science to decision-making. Definitions and concepts for ecological risk assessment can be defined analogously with those provided for human health risk assessment in the NRC's 1983 report, Risk Assessment in the Federal Government: Managing the Process. The scope of ecological risk assessment, defined in this way, is not limited to technical analyses supporting day-to-day regulatory decisions. Ecological risk assessment can also contribute to strategic planning within and between federal agencies and to clarifying the ongoing public debate concerning national and international environmental priorities. The four-part framework for health risk assessment (hazard identification, dose-response assessment, exposure assessment, risk characterization) described in the 1983 report insufficiently characterizes the interaction between science and management in risk assessment. Management considerations (e.g., regulatory constraints on the scope or time available for an assessment for legally prescribed definitions of acceptable or unacceptable risks) shape the hazard identification step. Communication of risks in terms relevant to decision-making is a critical aspect of risk characterization that was largely unexplored in the 1983 report. (This topic was explored in a subsequent NRC report, Improving Risk Communication (NRC, 1989)). Although the deficiencies were initially identified by the committee with respect to ecological risk assessment, the committee believes they are relevant to human health risk assessment as well.

OCR for page 266
Issues in Risk Assessment If the definitions used in the 1983 report are expanded then, with minor changes in terminology, a single framework can accommodate both human health and ecological risks. Hazard identification should be expanded to include identification of policy considerations or regulatory mandates that influence the scope and objectives of an assessment. Risk characterization should be expanded to provide explicit discussion of uncertainty, facilitate expression of risks and management-relevant terms, and emphasize the importance of communication between scientists and managers. Prospects for integration of human and ecological concerns into comprehensive environmental policies that are protective of both will be enhanced if the assessments employ a common framework and terminology. Several scientific problems are common to all types of ecological risk assessments. Most of them are now subjects of active scientific research: extrapolation across scales of time, space, and ecological organization; quantification of uncertainty; validation of predictive tools; and valuation, especially quantification, of nonuse values. Technical guidance is needed on the scientific content of ecological risk assessments. In-depth analysis of the scientific issues involved in specific applications of ecological risk assessment is beyond the charge of this committee. Additional expert committees drawn from the academic, public, and private sectors are needed to address these issues. The workshop summary (Appendix H) contains many specific examples of topics for which guidance is needed; the NRC's report Ecological Knowledge and Environmental Problem-Solving (NRC, 1986) provides a useful model for synthesis and presentation of the science relevant to improving ecological risk assessments.